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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Navident - 07540209955938

Calibrator
Claronav Inc
950-ND-CAL
In Commercial Distribution

  • 07540209955938 ()
950-ND-CAL

  • Surgical planning/navigation-enhancement system

Navident - 07540209955921

NaviTray
Claronav Inc
955-ND-NTRY
In Commercial Distribution

  • 07540209955921 ()
955-ND-NTRY

  • Surgical planning/navigation-enhancement system

Navident - 07540209955914

Jaw Tracker T (JTT43)
Claronav Inc
955-ND-JTTB-001
In Commercial Distribution

  • 07540209955914 ()
955-ND-JTTB-001

  • Surgical planning/navigation-enhancement system

Navident - 07540209955907

JawTracker T (JTT42)
Claronav Inc
955-ND-JTTC-001
In Commercial Distribution

  • 07540209955907 ()
955-ND-JTTC-001

  • Surgical planning/navigation-enhancement system

Navident - 07540209955891

Jaw Tracker T (JTT41)
Claronav Inc
955-ND-JTTA-001
In Commercial Distribution

  • 07540209955891 ()
955-ND-JTTA-001

  • Surgical planning/navigation-enhancement system

Navident - 07540209955884

Jaw Tracker 4U
Claronav Inc
955-ND-JTUC
In Commercial Distribution

  • 07540209955884 ()
955-ND-JTUC

  • Surgical planning/navigation-enhancement system

Navident - 07540209955877

Jaw Tracker 4C
Claronav Inc
955-ND-JCOM
In Commercial Distribution

  • 07540209955877 ()
955-ND-JCOM

  • Surgical planning/navigation-enhancement system

Navident - 07540209955860

Jaw Tracker 4B
Claronav Inc
955-ND-JBAT
In Commercial Distribution

  • 07540209955860 ()


  • Surgical planning/navigation-enhancement system

Navident - 07540209955853

High Speed Handpiece Tracker (HPT HS)
Claronav Inc
955-ND-HPTG-002
Not in Commercial Distribution

  • 07540209955853 ()
955-ND-HPTG-002

  • Surgical planning/navigation-enhancement system

Navident - 07540209955846

Low Speed Handpiece Tracker (HPT LS)
Claronav Inc
955-ND-HPTG-001
Not in Commercial Distribution

  • 07540209955846 ()
955-ND-HPTG-001

  • Surgical planning/navigation-enhancement system

Navident - 07540209955839

Tracer 4
Claronav Inc
955-ND-TRTO (Version 4)
In Commercial Distribution

  • 07540209955839 ()
955-ND-TRTO

  • Surgical planning/navigation-enhancement system

Navident - 07540209955822

Jaw Tracker T (JTT33)
Claronav Inc
955-ND-JTTB-000
In Commercial Distribution

  • 07540209955822 ()
955-ND-JTTB-000

  • Surgical planning/navigation-enhancement system

Navident - 07540209955815

Jaw Tracker T (JTT32)
Claronav Inc
955-ND-JTTC-000
In Commercial Distribution

  • 07540209955815 ()
955-ND-JTTC-000

  • Surgical planning/navigation-enhancement system

Navident - 07540209955808

Jaw Tracker T (JTT31)
Claronav Inc
955-ND-JTTA-000
In Commercial Distribution

  • 07540209955808 ()
955-ND-JTTA-000

  • Surgical planning/navigation-enhancement system

Navident - 07540209955792

Jaw Tracker U
Claronav Inc
955-ND-JTVU
In Commercial Distribution

  • 07540209955792 ()
955-ND-JTVU

  • Surgical planning/navigation-enhancement system

Navident - 07540209955785

Jaw Tracker C
Claronav Inc
955-ND-JTVC
In Commercial Distribution

  • 07540209955785 ()
955-ND-JTVC

  • Surgical planning/navigation-enhancement system

Navident - 07540209955778

Jaw Tracker B
Claronav Inc
955-ND-JTVB
In Commercial Distribution

  • 07540209955778 ()
955-ND-JTVB

  • Surgical planning/navigation-enhancement system

Navident - 07540209955761

Tracer 3
Claronav Inc
955-ND-TRTO (Version 3)
In Commercial Distribution

  • 07540209955761 ()
955-ND-TRTO

  • Surgical planning/navigation-enhancement system

Navident Training Kit - 07540209955044

Navident Training Kit for use with the Navident system
Claronav Inc
955-ND-NVTK
In Commercial Distribution

  • 07540209955044 ()


  • Surgical planning/navigation-enhancement system

Navident Accessory Kit - 07540209955037

Navident accessory kit for use with Navident System
Claronav Inc
955-ND-ACCK
In Commercial Distribution

  • 07540209955037 ()


  • Surgical planning/navigation-enhancement system

Navident - 07540209955006

Navident Surgical Navigation System - Packaged System (including kits/accessories)
Claronav Inc
955-ND-ND, plus kits
In Commercial Distribution

  • 07540209955006 ()


  • Surgical planning/navigation-enhancement system

SyMRI - 07340024700078

SyMRI is a post-processing software medical device intended for use in visualization of soft tissue. SyMRI analyzes input data from MR imaging systems. SyMRI utilizes data from supported MR sequences to generate parametric maps of R1, R2 relaxation rates, and proton density (PD). SyMRI is intended for automatic labeling, visualization and volumetric quantification of segmentable brain tissues from a set of MR images. Brain tissue volumes are determined based on modeling of parametric maps from SyMRI. SyMRI can also generate multiple image contrasts from the parametric maps. SyMRI enables post-acquisition image contrast adjustment. SyMRI is indicated for head imaging. When interpreted by a trained physician, output from SyMRI can provide information useful in determining diagnosis. SyMRI 2D is intended to be used in combination with at least one other, conventional MR acquisition (e.g. T2-FLAIR). T1W and T2W images from SyMRI 3D may replace conventional MR images in a clinical setting when interpreting together with a conventional 3D T2W FLAIR image.
SyntheticMR AB (publ)
15
In Commercial Distribution

  • 07340024700078 ()


  • MRI system application software

SyMRI - 07340024700030

SyMRI is a post-processing software medical device intended for use in visualization of the brain. SyMRI analyzes input data from MR imaging systems. SyMRI utilizes data from a multi-delay, multi-echo acquisition (MDME) to generate parametric maps of R1, R2 relaxation rates, and proton density (PD). SyMRI can generate multiple image contrasts from the parametric maps. SyMRI enables post-acquisition image contrast adjustment. SyMRI is indicated for head imaging. SyMRI is also intended for automatic labeling, visualization and volumetric quantification of segmentable brain tissues from a set of MR images. Brain tissue volumes are determined based on modeling of parametric maps from MDME images. When interpreted by a trained physician, SyMRI images can provide information useful in determining diagnosis. SyMRI should always be used in combination with at least one other, conventional MR acquisition (e.g. T2-FLAIR).
SyntheticMR AB (publ)
11
In Commercial Distribution

  • 07340024700030 ()


  • MRI system application software

SyMRI - 07340024700023

SyMRI is a post-processing software medical device intended for use in visualization of the brain. SyMRI analyzes input data from MR imaging systems. SyMRI utilizes data from a multi-delay, multi-echo acquisition (MDME) to generate parametric maps of R1, R2 relaxation rates, and proton density (PD). SyMRI can generate multiple image contrasts from the parametric maps. SyMRI enables post-acquisition image contrast adjustment. SyMRI is indicated for head imaging. When interpreted by a trained physician, SyMRI images can provide information useful in determining diagnosis. SyMRI should always be used in combination with at least one other, conventional MR acquisition (e.g. T2-FLAIR).
SyntheticMR AB (publ)
10
In Commercial Distribution

  • 07340024700023 ()


  • MRI system application software

SyMRI - 07340024700061

SyMRI is a post-processing software medical device intended for use in visualization of soft tissue. SyMRI analyzes input data from MR imaging systems. SyMRI utilizes data from supported MR sequences to generate parametric maps of R1, R2 relaxation rates, and proton density (PD). SyMRI is intended for automatic labeling, visualization and volumetric quantification of segmentable brain tissues from a set of MR images. Brain tissue volumes are determined based on modeling of parametric maps from SyMRI. When interpreted by a trained physician, the parametric maps, tissue maps, and volumetrics from SyMRI can provide information useful in determining diagnosis. SyMRI is indicated for head imaging. SyMRI can also generate multiple contrast weighted images from the parametric maps generated by post-processing data from M2D-MDME sequence. SyMRI enables post-acquisition image contrasts adjustments from acquisition using M2D-MDME sequence. When M2D-MDME acquisition data is used as input to SyMRI the synthetic contrast weighted images can also provide information useful in determining diagnosis. SyMRI is intended to be used in combination with at least one other, conventional MR acquisition (e.g. T2-FLAIR).
SyntheticMR AB (publ)
14
In Commercial Distribution

  • 07340024700061 ()


  • MRI system application software

BCI - 30610586038444

No Description
ICU MEDICAL, INC.
WW8214
In Commercial Distribution

  • 30610586038444 ()
  • 10610586038440 ()


  • Multiple vital physiological parameter monitoring system, clinical

Skyline 55 wireless - 18904269451537

Central Nursing Station or Central Monitoring System
SKANRAY TECHNOLOGIES LIMITED
F3-87-390-0075-46
In Commercial Distribution

  • 18904269451537 ()


  • Centralized patient monitor

Skyline 55 wireless - 18904269451520

Central Nursing Station or Central Monitoring System
SKANRAY TECHNOLOGIES LIMITED
F3-87-390-0074-49
In Commercial Distribution

  • 18904269451520 ()


  • Centralized patient monitor

Caduceus S - 24719878713065

No Description
Taiwan Main Orthopaedic Biotechnology Co., Ltd.
CDS-02
In Commercial Distribution

  • 24719878713065 ()


  • Surgical planning/navigation-enhancement system

Caduceus S - 24719878713058

No Description
Taiwan Main Orthopaedic Biotechnology Co., Ltd.
CDS-02
In Commercial Distribution

  • 24719878713058 ()


  • Surgical planning/navigation-enhancement system

Caduceus S - 24719878713041

No Description
Taiwan Main Orthopaedic Biotechnology Co., Ltd.
CDS-02
In Commercial Distribution

  • 24719878713041 ()


  • Surgical planning/navigation-enhancement system

Starling - 27290013030041

The Starling sensors are accessories to the Starling Monitor which provides continuous non-invasive monitoring of Cardiac Output and other key hemodynamic parameters of cardiac function.
CHEETAH MEDICAL (ISRAEL) LTD
CMS10
In Commercial Distribution

  • 07290013030047 ()
  • 27290013030041 ()
CMS10

  • Multiple vital physiological parameter monitoring system, clinical

EarlySense® Central Display Unit - 07290016169140

No Description
EARLYSENSE LTD
N/A
In Commercial Distribution

  • 07290016169140 ()
AME-002500 US

  • Centralized patient monitor

Starling - 07290013030290

The Starling Monitor provides continuous non-invasive monitoring of Cardiac Output and other key hemodynamic parameters of cardiac function, as well as blood pressure parameters and blood oxygen saturation levels.
CHEETAH MEDICAL (ISRAEL) LTD
CMMST5S
In Commercial Distribution

CMMST5S

  • Multiple vital physiological parameter monitoring system, clinical

Starling - 07290013030269

The Starling Monitor provides continuous non-invasive monitoring of Cardiac Output and other key hemodynamic parameters of cardiac function, as well as blood pressure parameters.
CHEETAH MEDICAL (ISRAEL) LTD
CMMST5
In Commercial Distribution

CMMST5

  • Multiple vital physiological parameter monitoring system, clinical

Starling SV - 07290013030030

A portable, non-invasive cardiac output (CO) monitoring device.
CHEETAH MEDICAL (ISRAEL) LTD
CMM-ST5
Not in Commercial Distribution

  • 07290013030030 ()
CMM-ST5

  • Multiple vital physiological parameter monitoring system, clinical

nordicMEDIVA - 07090042059084

nordicMEDiVA is a software as a medical device (SaMD) for processing of MR images of the brain. Users will configure analysis pipelines, which are executed automatically when image data is received or manually by a user. The user can choose to send the results to other DICOM nodes for review or use nordicView for their review and export the results to PACS, neuro navigation systems, or other DICOM-compliant modalities. nordicMEDiVA is a server-client solution and can be installed on a local server at the customer's location or in a cloud-based setup. The software is containerized with Docker technology and operates on a GPU-enabled Linux host. This allows customers to manage the server environment themselves or use it as a Software as a Service (SaaS) hosted by NordicImagingLab AS in the cloud. Customers can install the server on physical hardware or in their own cloud infrastructure. The device comprises a database, DICOM functionality, various APIs, a visualization engine, and medical image analysis modules. The device is not intended for long-term persistent storage of medical diagnostic data. The device incorporates rule-based algorithms for the calculation of metrics from dynamic MRI data. The device does not incorporate AI algorithms based on neural networks. The device connects to other imaging modalities, such as MR scanners, PACS, and surgical navigation systems.
Nordicneurolab AS
3
In Commercial Distribution

  • 07090042059084 ()


  • MRI system application software

nordicMEDIVA - 07090042059077

nordicMEDiVA is a software as a medical device (SaMD) for processing of MR images of the brain. Users will configure analysis pipelines, which are executed automatically when image data is received or manually by a user. The user can choose to send the results to other DICOM nodes for review or use nordicView for their review and export the results to PACS, neuro navigation systems, or other DICOM-compliant modalities. nordicMEDiVA is a server-client solution and can be installed on a local server at the customer's location or in a cloud-based setup. The software is containerized with Docker technology and operates on a GPU-enabled Linux host. This allows customers to manage the server environment themselves or use it as a Software as a Service (SaaS) hosted by NordicImagingLab AS in the cloud. Customers can install the server on physical hardware, virtual machines, or in their own cloud infrastructure. The device comprises a database, DICOM functionality, various APIs, a visualization engine, and medical image analysis modules. The device is not intended for long-term persistent storage of medical diagnostic data. The device incorporates rule-based algorithms for the calculation of metrics from dynamic MRI data. The device does not incorporate AI algorithms based on neural networks. The device connects to other imaging modalities, such as MR scanners, PACS, and surgical navigation systems.
Nordicneurolab AS
2
In Commercial Distribution

  • 07090042059077 ()


  • MRI system application software

nordicAktiva - 07090042059060

NordicNeuroLab’s nordicAktiva is a stimulus presentation and workflow software which controls the presentation of stimuli during fMRI exams and has been designed specifically with the clinical user in mind. With an intuitive interface and detailed, easy-to-follow instructions, the user is guided step-by-step through the process of presenting stimuli during MR image acquisition. nordicAktiva runs on the stimulus presentation PC to which the NNL fMRI Hardware System is connected. Through the latter audiovisual stimuli are presented to, and feedback is collected from the patient.
Nordicneurolab AS
2.0
In Commercial Distribution

  • 07090042059060 ()


  • MRI system application software

nordicDSC - 07090042059053

nordicDSC is an image analysis module that can be integrated into hospital infrastructure to analyze dynamic susceptibility contrast enhanced (DSC) perfusion data obtained from Magnetic Resonance Imaging (MRI). The product can be deployed on the nordicMEDiVA platform, or as a plugin to other software offerings.
Nordicneurolab AS
23.04
In Commercial Distribution

  • 07090042059053 ()


  • MRI system application software
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